510(k) · Cleared
ClearedNovotwist Needle, Models 30G * 8MM (1/3) 32 G Tip * 5 MM (1/5')
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novo Nordisk, Inc. · FMI Needle, Hypodermic, Single Lumen
Cleared on Jun 18, 2010 as substantially equivalent to K062500 (Novo Nordisk, Inc., 2006) and 3 other predicates after a 260-day review. Its family tree reaches back 4 generations to 1995. 4 later devices descend from it.
- Decided
- Jun 18, 2010
- Review
- 260 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K951254 (1995). 7 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK951254 Safetyglide NeedleBd Becton Dickinson Vacutainer Systems Preanalytic · 1995 · Recalled
- 3 generations backK050106 Novofine Autocover 30G X 8MMNovo Nordisk, Inc. · 2005
- 2 generations backK062500 Flexpen NeedleNovo Nordisk, Inc. · 2006
- 1 generation backK090111 Flexpen NeedleNovo Nordisk, Inc. · 2010
- This deviceK093109 Novotwist Needle, Models 30G * 8MM (1/3) 32 G Tip * 5 MM (1/5')Novo Nordisk, Inc. · 2010
- Descendant · cites it directly · 2 of its ownK133738 Novofine Plus 32G 4 MMNovo Nordisk, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK202005 NovoFine Plus 32G Tip x 4 mmNovo Nordisk, Inc. · 2020
- Descendant · 3 generations on · 0 of its ownK231255 NovoFine® PlusNovo Nordisk, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK120191 Push-on Needle 30GX8MMScandinavian Health Limited · 2012
Most influential descendants
Showing 4 of 4 · See all- K133738Novofine Plus 32G 4 MMNovo Nordisk, Inc. · 2014 · cites it directly2descendants
- K202005NovoFine Plus 32G Tip x 4 mmNovo Nordisk, Inc. · 2020 · 2 generations on1descendant
- K231255NovoFine® PlusNovo Nordisk, Inc. · 2023 · 3 generations on0descendants
- K120191Push-on Needle 30GX8MMScandinavian Health Limited · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K951254 | Safetyglide Needle | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995 | 4 |
| −3 | K050106 | Novofine Autocover 30G X 8MM | Novo Nordisk, Inc. | 2005 | — |
| −2 | K062500 | Flexpen Needle | Novo Nordisk, Inc. | 2006 | — |
| −1 | K090111 | Flexpen Needle | Novo Nordisk, Inc. | 2010 | — |
| 0 (this device) | K093109 | Novotwist Needle, Models 30G * 8MM (1/3) 32 G Tip * 5 MM (1/5') | Novo Nordisk, Inc. | 2010 | — |
| +1 | K133738 | Novofine Plus 32G 4 MM | Novo Nordisk, Inc. | 2014 | — |
| +2 | K202005 | NovoFine Plus 32G Tip x 4 mm | Novo Nordisk, Inc. | 2020 | — |
| +3 | K231255 | NovoFine® Plus | Novo Nordisk, Inc. | 2023 | — |
| +1 | K120191 | Push-on Needle 30GX8MM | Scandinavian Health Limited | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FMI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FMI device
- #1 K252886 Pen Needlescore 14.5 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K062500 | Flexpen NeedleSummary page 1…dles which are substantially equivalent to the Novo Nordisk's NovoFine® 320 Tip (0.23/ 0.25 mm) x 6 mm disposable needle, cleared under 5 10(k) K(062500 and K(09011I1, tothe NovaFine® Autacovero 30G x 8 mm disposable needle, cleared under 5 10(k) K(050106, and tothe BD… | 2006 |
| * | K090111 | Flexpen Needle Cleared while this submission was under review | 2010 |
| * | K050106 | Novofine Autocover 30G X 8MMSummary page 1…disposable needle, cleared under 5 10(k) K(062500 and K(09011I1, tothe NovaFine® Autacovero 30G x 8 mm disposable needle, cleared under 5 10(k) K(050106, and tothe BD Pen needle, cleared under 510(k) K051899. The term "substantial equivalence" as used in this 5 10(k) no… | 2005 |
| * | K051899 | BD Pen NeedleSummary page 1…(062500 and K(09011I1, tothe NovaFine® Autacovero 30G x 8 mm disposable needle, cleared under 5 10(k) K(050106, and tothe BD Pen needle, cleared under 510(k) K051899. The term "substantial equivalence" as used in this 5 10(k) notification is limited to the definition of… | 2005 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K133738 (Novo Nordisk, Inc., 2014) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K062500.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · FMI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMI
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMI
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FMI
2,424in 2025
MAUDE reports naming product code FMI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 71 | 2 | 208 |
| 2008 | 10 | 85 | 4 | 177 |
| 2009 | 7 | 177 | 3 | 263 |
| 2010 | 15 | 119 | 79 | 249 |
| 2011 | 12 | 113 | 5 | 240 |
| 2012 | 17 | 107 | 1 | 215 |
| 2013 | 11 | 87 | 1 | 255 |
| 2014 | 14 | 155 | 3 | 287 |
| 2015 | 10 | 89 | 1 | 567 |
| 2016 | 20 | 217 | 0 | 941 |
| 2017 | 9 | 253 | 16 | 1,547 |
| 2018 | 20 | 176 | 0 | 2,398 |
| 2019 | 12 | 186 | 5 | 4,896 |
| 2020 | 11 | 263 | 3 | 4,245 |
| 2021 | 18 | 143 | 7 | 4,532 |
| 2022 | 23 | 189 | 0 | 4,885 |
| 2023 | 18 | 112 | 2 | 4,986 |
| 2024 | 3 | 90 | 1 | 4,053 |
| 2025 | 11 | 141 | 0 | 2,424 |
| 2026 | 12 | 119 | 1 (1) | — |
What is it indicated for?
NovoTwist® needles are intended for use with pen injector devices for the subcutaneous injection of insulin, liraglutide and somatropin
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K093109 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093109: Novotwist Needle, Models 30G * 8MM (1/3) 32 G Tip * 5 MM (1/5').” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093109
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026